Apical CystNCT06384014
Examining the Effect of Different Filling Techniques on Healing in Lesional Teeth
A study testing retrograde and orthograde root canal filling in people with Apical Cyst, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Microorganisms are an important factor in the development of periradicular diseases. The goal of non-surgical endodontic treatment is to eliminate microorganisms and their byproducts from the root canal system and to create an effective barrier between the root canal system and surrounding tissues. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Cyst
- What is being tested?
- retrograde and orthograde root canal filling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2024to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients aged between 18 and 65 years with persistent symptomatic apical pathology, characterized by pain on biting and/or percussion sensitivity, who provided written informed consent for the surgical procedure and follow-up examinations.
- 2. Patients with a non-contributory medical history, classified as American Society of Anesthesiologists (ASA) Class I or II.
- 3. Single-rooted anterior teeth with true endodontic lesions classified as Type B or C according to Kim and Kratchman's classification (Table 1).1 4. Single-rooted anterior teeth without significant canal calcification or obliteration, significant root curvature, or anatomical abnormalities.
- 5. Teeth deemed restorable with sufficient remaining coronal structure to support a definitive restoration.
- 6. Periodontally healthy teeth, defined as probing depths ≤ 6 mm, absence of pathological mobility, and no furcation involvement Exclusion criteria
- Patients with systemic diseases that contraindicate surgical procedures (e.g., uncontrolled diabetes, coagulation disorders, immunosuppression).
Show all 12Show fewer
- Patients taking medications that may affect bone metabolism or healing (e.g., bisphosphonates, corticosteroids, anticoagulants).
- Pregnant or breastfeeding patients.
- Teeth with vertical root fractures, perforations, or external root resorption.
- Teeth with insufficient bone support or an unfavorable crown-to-root ratio as determined by clinical and radiographic assessment.
- Patients who declined follow-up participation or were unable to commit to the scheduled follow-up examinations.
- Teeth in which orthograde MTA obturation could not be completed intraoperatively due to anatomical limitations were to be excluded from analysis; however, no such cases were encountered in this trial.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes Üniversitesi Diş Hekimliği Fakültesi
Kayseri, Kayseri, 38039
About this study
Official title: Comparison of the Effect of Orthograde and Retrograde Mineral Trioxide Aggregate Application on Healing After Apical Resection in Teeth With Periapical Lesions
Microorganisms are an important factor in the development of periradicular diseases. The goal of non-surgical endodontic treatment is to eliminate microorganisms and their byproducts from the root canal system and to create an effective barrier between the root canal system and surrounding tissues. If there is no healing in the periradicular tissues after non-surgical endodontic treatment or if retreatment becomes impossible, surgical endodontic treatment is required. Apical resection is a surgical technique that involves removing the root tip of the tooth and closing the apical portion of the root canal system. An ideal retrograde filling material should be non-toxic, non-carcinogenic and biocompatible. It must also have dimensional stability and sealing properties. Amalgam, glass ionomer cements, and zinc oxide-eugenol based materials have been used for root end fillings in periapical surgery, but the desired success was not achieved. Today, Mineral Trioxide Aggregate (MTA) is preferred as a retrograde filling material due to its superior sealing properties, ability to harden in the presence of blood and moisture, antibacterial effects, biocompatibility and radiopacity.
In the researchers' study, the effect of apical resection after orthograde canal filling and retrograde canal filling during apical resection on postoperative recovery will be compared. In both canal filling techniques, Sure-Seal Root MTA (Sure Dent Corporation-Korea) will be used as the filling material. Sure-Seal Root MTA is a calcium silicate based paste that is typically pre-mixed and ready to apply, exhibits excellent physical properties and does not show shrinkage during the curing process. As the manufacturer states, it is hydrophilic, biocompatible, has ideal setting and working time.
Our faculty has piezosurgical ultrasonics (Mectron ®, Grassobbio BG, Italy). After the root tip resection is performed, the retrograde cavity will be prepared with Woodpecker ultrasonic tips (Guilin, China) compatible with this device. In our study using these materials and devices, a comparative analysis of the effects of different canal filling techniques on lesion healing and improvement in clinical symptoms will be made.
Read the detailed description
Periapical or periradicular lesions are barriers that restrict microorganisms and prevent their spread to surrounding tissues; microorganisms cause periapical lesions, either primary or secondary. Apical infections, if left untreated, can follow two different paths: First, the infection can create a path inside or outside the mouth, causing the pus to drain out. Secondly, infection within the canal; It may reach the periapical tissues and create a cavity surrounded by polymorphonuclear leukocytes in the bone, leading to the formation of inflammatory radicular cysts.
Inflammatory radicular cysts (IRCs) are chronic lesions that occur after the development of periapical granulomas (PGs). PGs and IRCs are thought to follow pulp infections as an inflammatory process at the periapical level. Although both conditions, PG and IRC, are clinically diagnosed as apical periodontitis (AP), they differ significantly histopathologically.
The majority of apical cysts are asymptomatic and may develop insidiously by being discovered incidentally during a routine x-ray examination as a large periapical radiolucency covering the apex of one or more teeth. By confirming that the lesion is a granuloma or cyst, a more definitive diagnosis is reached by histopathological examination. Although conventional radiographic methods cannot be used for the definitive diagnosis of periapical cysts, larger round or oval, well-circumscribed radiolucent images around the apex of the tooth are considered to be cystic lesions.
When the infection in the canal is successfully treated, apical cysts can regress by the apoptosis mechanism in the root canal without the need for surgical intervention. Researchers stated that incorrect histopathological diagnosis in early studies created the false impression that radicular cysts were more common, and that this methodological error led to the illusion that most cystic lesions in the periapex area healed after non-surgical root canal treatment. In conclusion, the authors suggested that true cysts may be less likely to heal with nonsurgical root canal treatment due to their inherently self-sustaining properties and may require surgical intervention. Whether true cysts heal after non-surgical root canal treatment is still a major debate.
Different retrograde canal filling materials have been tried in the literature, but today, Mineral Trioxide Aggregate (MTA) is most commonly used because it is more biocompatible and has a periapical healing-inducing effect. MTA; It is the first restorative material that allows cementum development and provides regeneration in periodontal ligament cells. In addition, histological sections taken from the periapical region of teeth with retrograde canal filling with MTA often showed new cementum formation not only on the resection surface but also directly on the MTA. For this reason, MTA is called bioactive material. Properties of MTA such as biocompatibility, sealing, and the capacity to increase the regeneration of pulp and periradicular tissues; It has increased the diversity of dental usage areas and clinical success rates, and has become the focus of attention of clinicians with this innovative structure. In comparative studies on retrograde filling materials, MTA has demonstrated an excellent tissue response with almost no inflammatory component.
There are few studies in the literature comparing the effects of two different canal filling techniques (orthograde, retrograde), which are currently frequently used, on postoperative recovery. There is no study comparing the long-term postoperative radiographic and clinical improvement levels of using MTA with different application techniques in teeth with periapical lesions with an indication for apical resection. The purpose of researchers' planned study is to compare and evaluate the healing effect of orthograde MTA application followed by resection in teeth with large periapical lesions and retrograde MTA application during apical resection operation.
- Conditions
- Apical Cyst
- Being tested
- retrograde and orthograde root canal filling
- Medical subject headings
- Radicular Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrograde and orthograde root canal fillingDevice
Apical resection application after root canal filling
| Study group | Role | What they receive |
|---|---|---|
| Retrograde canal filling technique | Active comparator | Apical resection application after retrograde root canal filling Receives: Device: retrograde and orthograde root canal filling |
| Orthograde canal filling technique | Active comparator | Apical resection application after orthograde root canal filling Receives: Device: retrograde and orthograde root canal filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of lesion healing rate after apical resection using different root canal filling techniques
lesion healing rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start8 May 2024
- Primary completion5 Aug 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical CystStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- İki farklı grupta farklı kanal dolum teknikleri uygulandıktan sonra apikal rezeksiyon yapılarak lezyon iyileşmesinin değerlendirilmesi
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ipek Eraslan Akyuz, TC Erciyes University
- Investigators
- ERASLAN AKYÜZ, Principal investigator, BAŞ ARAŞTIRMACITOPÇUOĞLU, Study director, YÜRÜTÜCÜÖZDEMİR, Study chair, YARDIMCI ARAŞTIRMACI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384014
- Sponsor's protocol ID
- 2024/56
- Status last verified
- Sep 2026
- First submitted
- 18 Apr 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Orthograde and Retrograde Mineral Trioxide Aggregate Application on Healing After Apical Resection in Teeth With Periapical Lesions
- ClinicalTrials.gov ID
- NCT06384014
- Acronym / sponsor ID
- 2024/56
- Conditions
- Apical Cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Microorganisms are an important factor in the development of periradicular diseases. The goal of non-surgical endodontic treatment is to eliminate microorganisms and their byproducts from the root canal system and to create an effective barrier between the root canal system and surrounding tissues. If there is no healing in the periradicular tissues after non-surgical endodontic treatment or if retreatment becomes impossible, surgical endodontic treatment is required. Apical resection is a surgical technique that involves removing the root tip of the tooth and closing the apical portion of the root canal system. An ideal retrograde filling material should be non-toxic, non-carcinogenic and biocompatible. It must also have dimensional stability and sealing properties. Amalgam, glass ionomer cements, and zinc oxide-eugenol based materials have been used for root end fillings in periapical surgery, but the desired success was not achieved. Today, Mineral Trioxide Aggregate (MTA) is preferred as a retrograde filling material due to its superior sealing properties, ability to harden in the presence of blood and moisture, antibacterial effects, biocompatibility and radiopacity.
In the researchers' study, the effect of apical resection after orthograde canal filling and retrograde canal filling during apical resection on postoperative recovery will be compared. In both canal filling techniques, Sure-Seal Root MTA (Sure Dent Corporation-Korea) will be used as the filling material. Sure-Seal Root MTA is a calcium silicate based paste that is typically pre-mixed and ready to apply, exhibits excellent physical properties and does not show shrinkage during the curing process. As the manufacturer states, it is hydrophilic, biocompatible, has ideal setting and working time.
Our faculty has piezosurgical ultrasonics (Mectron ®, Grassobbio BG, Italy). After the root tip resection is performed, the retrograde cavity will be prepared with Woodpecker ultrasonic tips (Guilin, China) compatible with this device. In our study using these materials and devices, a comparative analysis of the effects of different canal filling techniques on lesion healing and improvement in clinical symptoms will be made.
Detailed description
Periapical or periradicular lesions are barriers that restrict microorganisms and prevent their spread to surrounding tissues; microorganisms cause periapical lesions, either primary or secondary. Apical infections, if left untreated, can follow two different paths: First, the infection can create a path inside or outside the mouth, causing the pus to drain out. Secondly, infection within the canal; It may reach the periapical tissues and create a cavity surrounded by polymorphonuclear leukocytes in the bone, leading to the formation of inflammatory radicular cysts.
Inflammatory radicular cysts (IRCs) are chronic lesions that occur after the development of periapical granulomas (PGs). PGs and IRCs are thought to follow pulp infections as an inflammatory process at the periapical level. Although both conditions, PG and IRC, are clinically diagnosed as apical periodontitis (AP), they differ significantly histopathologically.
The majority of apical cysts are asymptomatic and may develop insidiously by being discovered incidentally during a routine x-ray examination as a large periapical radiolucency covering the apex of one or more teeth. By confirming that the lesion is a granuloma or cyst, a more definitive diagnosis is reached by histopathological examination. Although conventional radiographic methods cannot be used for the definitive diagnosis of periapical cysts, larger round or oval, well-circumscribed radiolucent images around the apex of the tooth are considered to be cystic lesions.
When the infection in the canal is successfully treated, apical cysts can regress by the apoptosis mechanism in the root canal without the need for surgical intervention. Researchers stated that incorrect histopathological diagnosis in early studies created the false impression that radicular cysts were more common, and that this methodological error led to the illusion that most cystic lesions in the periapex area healed after non-surgical root canal treatment. In conclusion, the authors suggested that true cysts may be less likely to heal with nonsurgical root canal treatment due to their inherently self-sustaining properties and may require surgical intervention. Whether true cysts heal after non-surgical root canal treatment is still a major debate.
Different retrograde canal filling materials have been tried in the literature, but today, Mineral Trioxide Aggregate (MTA) is most commonly used because it is more biocompatible and has a periapical healing-inducing effect. MTA; It is the first restorative material that allows cementum development and provides regeneration in periodontal ligament cells. In addition, histological sections taken from the periapical region of teeth with retrograde canal filling with MTA often showed new cementum formation not only on the resection surface but also directly on the MTA. For this reason, MTA is called bioactive material. Properties of MTA such as biocompatibility, sealing, and the capacity to increase the regeneration of pulp and periradicular tissues; It has increased the diversity of dental usage areas and clinical success rates, and has become the focus of attention of clinicians with this innovative structure. In comparative studies on retrograde filling materials, MTA has demonstrated an excellent tissue response with almost no inflammatory component.
There are few studies in the literature comparing the effects of two different canal filling techniques (orthograde, retrograde), which are currently frequently used, on postoperative recovery. There is no study comparing the long-term postoperative radiographic and clinical improvement levels of using MTA with different application techniques in teeth with periapical lesions with an indication for apical resection. The purpose of researchers' planned study is to compare and evaluate the healing effect of orthograde MTA application followed by resection in teeth with large periapical lesions and retrograde MTA application during apical resection operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- İki farklı grupta farklı kanal dolum teknikleri uygulandıktan sonra apikal rezeksiyon yapılarak lezyon iyileşmesinin değerlendirilmesi
| Arm | Type | Receives |
|---|---|---|
| Retrograde canal filling technique | Active comparator | Device: retrograde and orthograde root canal fillingApical resection application after retrograde root canal filling |
| Orthograde canal filling technique | Active comparator | Device: retrograde and orthograde root canal fillingApical resection application after orthograde root canal filling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Patients aged between 18 and 65 years with persistent symptomatic apical pathology, characterized by pain on biting and/or percussion sensitivity, who provided written informed consent for the surgical procedure and follow-up examinations.
- 2. Patients with a non-contributory medical history, classified as American Society of Anesthesiologists (ASA) Class I or II.
- 3. Single-rooted anterior teeth with true endodontic lesions classified as Type B or C according to Kim and Kratchman's classification (Table 1).1 4. Single-rooted anterior teeth without significant canal calcification or obliteration, significant root curvature, or anatomical abnormalities.
- 5. Teeth deemed restorable with sufficient remaining coronal structure to support a definitive restoration.
- 6. Periodontally healthy teeth, defined as probing depths ≤ 6 mm, absence of pathological mobility, and no furcation involvement Exclusion criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrograde and orthograde root canal fillingApical resection application after root canal filling | Device | Orthograde canal filling technique, Retrograde canal filling technique |
Primary outcome
Comparison of lesion healing rate after apical resection using different root canal filling techniques
Time frame: 2 years
lesion healing rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Related trials for Apical Cyst
Recruiting
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
Apical Periodontitis, Endodontically Treated Teeth
RecruitingObservational study
Factors Affecting the Endodontic Treatment Outcome
Apical Periodontitis, Apical Granuloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ERASLAN AKYÜZ principal investigator
BAŞ ARAŞTIRMACI
TOPÇUOĞLU study director
YÜRÜTÜCÜ
ÖZDEMİR study chair
YARDIMCI ARAŞTIRMACI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retrograde and orthograde root canal filling in people with Apical Cyst, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of lesion healing rate after apical resection using different root canal filling techniques (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.